Biopharmaceutical firm BeiGene has received approval from the China Food and Drug Administration (CFDA) for the use of its Revlimid (lenalidomide) to treat newly diagnosed multiple myeloma (MM) patients.
The oral immunomodulatory drug is indicated as a combination therapy with dexamethasone for adults who did not undergo any prior treatment and are not eligible for transplant.
Revlimid was initially approved in 2013 by the CFDA to be given in conjunction with dexamethasone for adults suffering from multiple myeloma and had a minimum of one previous therapy.
The company is currently marketing the drug under an exclusive licence obtained from Celgene.
BeiGene founder, CEO and chairman John Oyler said: “Revlimid is an important part of our commercial and development plans in China, where we are expanding our portfolio and commercial footprint.
“In China, where the incidence of multiple myeloma is on the rise due to an aging population and improved diagnosis, we are hopeful that newly diagnosed patients will have a meaningful long-term benefit from this approval.”
The latest approval was based on findings from a randomised, three-arm, open-label Phase III clinical trial conducted to evaluate the safety and efficacy of Revlimid and low-dose dexamethasone (Rd) compared to melphalan, prednisone and thalidomide (MPT).
According to the data, continuous Rd significantly improved median progression-free survival (PFS), as well as demonstrated a longer median overall survival and higher response rate.
The most common adverse events during the trial were found to be neutropenia, anaemia, thrombocytopenia and pneumonia.